Have you reviewed your audit trail lately? What is it telling you and your team? We all understand the importance of audit trails, and companies review audit trails in one way or another, but does your staff truly understand what the audit trail is stating? Processes in a GxP environment should be developed and implemented […]
The 16th annual WRIB (Workshop on Recent Issues of Bioanalysis) is being held in Atlanta, GA this week with approximately 800 attendees at the workshop. The workshop which runs through Friday, is well represented by regulators from across globe, and industry (both from Pharma and CROs) with numerous discussions and topics for bioanalysis ranging from […]
The MHRA Good Clinical Practice Symposium was a virtual event this year due to COVID‑19. More than 800 individuals from over forty countries across the globe attended. Throughout the three‑day event, speakers provided their perspectives on clinical trials from their roles as inspectors, assessors, and reviewers representing the MHRA, FDA, and Health Canada. The agenda provided […]
On January 15, 2021, the FDA issued the guidance titled “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”. This guidance provides recommendations to study sponsors for the continuation or initiation of their bioequivalence (BE) studies during this COVID-19 public health emergency. As is no surprise, FDA clearly […]
For all Sponsors submitting INDs, NDAs, ANDAs, BLAs, and supplements, and the bioanalytical laboratories analyzing and reporting the data to support these submissions, the FDA just issued its Guidance for Industry, “Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers.” The Q&A guidance contains five questions, along with the Agency’s current thinking on […]
The 13th annual WRIB (Workshop on Recent Issues of Bioanalysis) was held in New Orleans, LA this week and is wrapping up today. The workshop was well represented by regulators and industry (both from Pharma and CROs), with numerous discussions and topics for the bioanalysis of small and large molecules. Presentations covered the full spectrum […]
Earlier last week, the U.S. FDA released its final guidance document, “Bioanalytical Method Validation.” This is great news as the bioanalytical industry has been waiting for the draft guidance (issued September 2013) to be finalized. For all bioanalytical laboratories that were following the previously issued final guidance, “Bioanalytical Method Validation” issued in May 2001, or the […]
The US FDA just released their Guidance for Industry titled “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)” (here). The guidance provides a path forward for the mutual acceptance of clinical trial data across regulatory authorities from Canada, the European Union, Japan, Switzerland, and the United States. The guidance clearly identifies the added revisions, […]
The 11th annual Workshop on Recent Issues in Bioanalysis (WRIB) has ended in sunny Hollywood, CA. The WRIB provides an opportunity for both industry and regulators to discuss challenges facing the bioanalytical community in the analysis of both small and large molecules. This year’s workshop had the largest turnout ever, with approximately 750 attendees from […]
